ANALYSIS OF USABILITY IN MEDICAL DEVICES PRODUCED BY ADDITIVE MANUFACTURING. CASE STUDY: SCALPEL HOLDER.
Keywords:
ditive Manufacturing, Usability, Occupational Safety and Medical DevicesAbstract
This study investigates the usability of medical devices manufactured by Additive Manufacturing, focusing on acceptance and safety by healthcare professionals. Considering the growing adoption of this technology in Industry 4.0, the authors highlight the need for rigorous standards to ensure the effectiveness and safety of products. The research is based on the ISO/IEC 62366-1:2021 standard, which defines usability as the ability of a device to be used effectively, efficiently, and satisfactorily. The PROTeMA Project was developed to test devices in real-world environments, reducing the risks of accidents involving sharps materials. The study was carried out at the Surgical Center of HUB-UnB, applying questionnaires and interviews to evaluate users’ experience with a 3D-printed scalpel holder. The analysis was conducted using UX (user experience) methods and the System Usability Scale (SUS) metric. The results indicated an average usability score of 49.48, classified as “poor” on the SUS scale. However, professionals considered the device useful and safe, although some pointed out initial handling difficulties. Factors such as age and years of experience have a significant impact on ease of use. Challenges included reconciling hospital routines with data collection and initial resistance from professionals. Despite this, the research reinforces that Additive Manufacturing can innovate in healthcare, making devices more accessible and customizable.
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